PPE Certification Program
While the most effective way to stop a virus is to maintain physical distancing and proper hand hygiene, the use of face masks can help the person wearing the mask to not spread infected droplets to others and to self-protect them selves from inhaling incoming viral particles from others.
NON-POWERED AIR PURIFYING RESPIRATORS
Canada
Currently, in Canada there is no dedicated national industry standard to regulate the safety and performance of medical masks for healthcare professionals or the general public. While the requirements are under development, Health Canada has accepted testing and certification to 42CFR84; ASTM F2100 and other internationally published standards.
LabTest Certification Inc. offers Testing and Certification for Non-Powered Air-Purifying Respirators in accordance with NIOSH 42 CFR 84 test procedures for marking the masks for 95PFE, 99PFE, and 100PFE, as per the internal requirements set by Health Canada.
LabTest also provides testing services to 16 CFR 1610 and ASTM F1862 / F1862M-17 for labelling 95PFE-L#, 99PFE-L# and 100PFE-L# respirators (where # represents the fluid resistance level) and for labelling surgical masks.
For Face Coverings not intended for a health care setting, LabTest is also Testing and Certifying Masks to ASTM-F3520
United States
In the USA, all medical masks for healthcare professionals are certified by The National Institute for Occupational Safety and Heath (NIOSH). LabTest provides Pre-Certification Testing in compliance with NIOSH-42CFR84 for Non-Powered Air-Purifying Respirators, such as N95, N99, and N100.
How to choose the right mask?
How to choose the right mask?
There are different types of protective masks available on the market, such as surgical masks, respirators and reusable (fabric) masks. The filtration efficiency varies between masks based on many different factors.
Surgical masks are commonly tested to ASTM-F2100 standards which includes:
- Particulate Filtration Efficiency
- Fluid Resistance
- Bacterial Filtration Efficiency
- Differential Pressure
- Flame Spread
Respirators have been an important tool in the health care settings since the start of the pandemic. Respirators are commonly tested for the following:
- Biocompatibility
- Particulate Filtration Efficiency
- Mechanical Strength of head strap
- Airflow Resistance
- Fit test
Reusable masks have hit the Canadian market since the pandemic started, and made a shortage in respirators. The challenge has been that most consumer masks on the Canadian and American market have not gone through any regulated testing since there was no standard developed for these masks… until NOW!
The ASTM-F3502 is a Standard that was designed to test consumers’ masks to ensure that they are up to standard. This standard includes the following tests:
- Particulate Filtration Efficiency
- Airflow Resistance
- Design, fit and labeling Requirements
During the COVID-19 global pandemic, as the world sees an increase in the demand for Personal Protective Equipment (PPE), and specifically for face masks, third-party approval of protective equipment is critical to ensure that it meets the required safety specifications, before being placed on the market.
LC compliance reports provide manufacturers of face coverings with the validation that their product provides the minimum level of protection against the intended risk.
Just because you are not in a health care setting, it does not mean you do not deserve to know the quality of your PPE. ASTM-F3502 is a standard designed specifically for masks that are not intended for a heath care setting. Similarly, to Respirators and Surgical masks, this standard tests consumer masks for their Particulate Filtration Efficiency and Airflow Resistance, along with checking their design and labeling to ensure that they reach all the necessary requirements.
Different types of Testing for Facial Coverings
Airflow Resistance Test (42 CFR 84.172)
The Airflow Resistance test consists of determining the resistance of the mask to inhalation and exhalation. For each determination, the mask is mounted on the test equipment and the air is set to flow at a rate of 85 liters per minute. Respirators must meet the following requirements:
Inhalation Test
Inhalation Test
Exhalation Test
Exhalation Test
Flammability Test (16 CFR Part 1610)
Textile specimens (50 x 150mm) are inserted in a frame and held in a special apparatus at an angle of 45°. A standardized flame is applied to the surface for one second near the low end of the specimen.
The time required for the flame to proceed up the fabric is recorded.
The textile shall be classified as Class 1 (normal flammability), Class 2 (intermediate flammability) or Class 3 (rapid and intense burning) based on the burn times recorded.
Mechanical strength of head strap or head harness
This will test the straps ability to withstand a 10 N weight force for each head strap tested. The test is a pass if there is no signs of breakage, tearing, permanent deformation or any other obvious loss of function.
Fluid resistance (ASTM-F1862)
This test is to measure the resistance of the mask to penetration by synthetic blood. The masks will be tested with fluid velocities of 450, 550 and 635 cm/s. The maximum level reached will be reported in the labeling.
Additional tests that might apply to Facial Coverings
Fit Test (each size) CAN/CSA Z94.4
Quantitative face fit testing using a TSI Porta Count tester (or equivalent device) should be performed in accordance with CSA Z94.4-18. Annex B of CSA Z94.4-18 outlines the 7 exercises and Annex C outlines the full protocol for the quantitative fit test procedure.
Bacterial Filtration Efficiency
The Bacterial Filtration Efficiency is a test performed on materials used to protect against biological aerosols. This test is much like the PFE test but instead of using solid sodium chloride particulate aerosol, the BFE test uses viable particles (bacteria).
Biocompatibility – ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin sensitization and hypersensitivity)
When making a mask, it is important to think of the safety of the people wearing it. Each finished component of the Face coverings should be tested for Biocompatibility, for materials should be non-cytotoxic, non-sensitizing and non-allergenic.
What Is A Respirator?
As the Coronavirus outbreak continues, we have all become familiar with protective face masks, especially the N95 respirators. Compared with other types of protective masks, N95 respirators are designed to form a seal around the user’s nose and mouth, which may not be the case with other types masks, like for example, surgical masks. N95 respirators filtrate most particles larger than 0.06 microns in diameter and therefore, protect from viruses like the coronavirus, which usually has a diameter above 0.08 microns.
What does N95 stand for?
This is the rating of a non-powered filtering respirator that’s “not resistant to oil” and that has a minimum efficiency rating of 95%. What does that mean? This means that less than 5% of particles pass through the mask when tested using sodium chloride aerosol.
There are 3 main types of (non-powered) Air-Purifying Respirators:
N (Non-resistant to oil)
R (Resistant to oil)
P (oil Proof)
Respirator Ratings Comparison
Respirator Ratings Comparison
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